FDA Commissioner Eyes New Drugmaker Rules, Including More Doctor Training On Opioids
Scott Gottlieb says the Food and Drug Administration will start to require that pharmaceutical companies offer more prescriber education for immediate-release opioids, which make up 90 percent of prescriptions.
The Washington Post:
FDA Chief To Impose Tougher Doctor-Training Rules On Opioid Manufacturers
Food and Drug Administration Commissioner Scott Gottlieb, stepping up the agency's efforts against the nation's opioid epidemic, announced plans Monday to require manufacturers of painkillers to provide more extensive education for physicians and other health-care professionals who prescribe the drugs. In remarks that opened a two-day FDA meeting on painkiller abuse, Gottlieb said the agency will now require makers of immediate-release opioids to provide prescriber training. These formulations, which account for 90 percent of the opioids prescribed in the United States, include hydrocodone as well as oxycodone/acetaminophen combinations. (McGinley, 7/10)
The Wall Street Journal:
FDA Commissioner Seeks New Standards For Some Opioid Prescriptions
“It’s time to take direct action to address the close to 200 million opioid analgesic prescriptions each year that are for the immediate release products,” the commissioner said. “The new training will be aimed at making sure providers who write prescriptions for the IR opioids are doing so for properly indicated patients, and under appropriate clinical circumstances.” (Burton, 7/10)
Bloomberg:
FDA Chief Says Agency Must Do More To Stop Abuse Of Opioids
The U.S.’s top drug regulator said on Monday that more must be done to stem the country’s tide of opioid addiction, proposing new guidelines and restrictions on some of the most widely used pain pills. Food and Drug Administration Commissioner Scott Gottlieb laid out plans to have drugmakers conduct doctor education programs on immediate-release opioids, which account for 90 percent of the 200 million opioid painkiller prescriptions written in the U.S. each year. The agency is also exploring whether pain-management training should be required for doctors as well as nurses, pharmacists or other health-care providers. (Edney, 7/10)
Politico Pro:
FDA Takes Steps Toward Mandating Opioid Training For Docs
The FDA on Monday required that all immediate-release opioids come under a special safety regime known as a risk evaluation and mitigation strategy. Manufacturers will be required to make training available for health professionals who prescribe the drugs and patients will get counseling documents on how to safely use the powerful pain medications. (Karlin-Smith, 7/10)
And in other news on the opioid epidemic —
Modern Healthcare:
Scramble Is On To Find New Ways To Stop Opioid Overdose Deaths
Last April, after a paramedic helped a colleague's relative get treatment for his addiction, the city launched the Safe Station Program. Now, all 10 of Manchester's firehouses are a safe haven where people struggling with addiction can seek assistance. Paramedics are available 24 hours a day, 7 days a week, to conduct a full medical evaluation before transporting the patient to a local hospital's emergency department or a treatment facility. (Johnson, 7/10)
The Washington Post:
A Drug Company Tried To Make Opioids Harder To Abuse. It Backfired.
Amid broad efforts to help people avoid prescription-opioid addiction, some pharmaceutical companies are taking an intriguing approach: making prescription opioids that can’t be misused. Although the tactic may at first blush seem a miracle cure, it has a decidedly mixed record of success. (Humphreys, 7/10)
